Principal Systems Engineer - Embedded(HYBRID - Open to Relocation)

Work Flexibility: Hybrid or Onsite

Who We Want:

• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
• Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do

Technical Competencies:

• Lead technical team members in the design, development, modification, and evaluation of design modules, sub-systems, or assemblies.
• Translate user needs to design inputs/ specifications and produce architectural-level layouts and platform designs.
• Able to architect an entire complex system, defining interfaces and dependencies between components. Easily solves complex system-level issues.
• Lead and mentor teams to solve significant and unique issues where analysis of situations or data requires evaluation of minimally defined problems.
• Work on the system aspects of a robotic system platform with customers across the globe.
• Design, write and deploy robotic system hardware, software, and firmware while meeting company quality expectations for effectiveness, reliability, and safety.
• Design, write and deploy subsystem test platforms and protocols.
• Interact with internal customers and marketing to draft/update customer, system, and subsystem requirements.
• Coordinate with mechanical, electrical, software, and system engineers to ensure that the system and subsystems designs meet specified requirements.
• Analyze system and subsystems requirements to ensure they are clear and verifiable, and that traceability of requirements is accurately captured and documented.
• Incorporate post-market data into designs with targeted precision.
• Collaborate in the development and execution of plans, protocols, and reports for verification and validation (V&V).
• Use common software tools, such as SolidWorks for CAD/CAM, Minitab for statistical analysis, and MATLAB for analysis through scripting.
• Apply FDA regulatory guidance, such as ISO 13485 / 14971 / 62304, to biomedical device development.
• Collaborate with Quality Assurance in analysis for the device risk management file, including failure modes and effects analysis (FMEA) and fault tree analysis (FTA).
• Collaborate with technical writers to create and revise documentation.

Business Responsibilities:

• Possess an in-depth knowledge of the industry and competitive landscape
• Partner with customers, internal and external key opinion leaders to develop technical strategies that meet clinical needs
• Strategize and execute customer-facing activities like the voice of customer and customer-centric design across the business
• Collaborate on Financial /business modeling and support business reviews to validate a technical approach
• Lead cooperative efforts to ensure the design meets the needs of all stakeholders
• Lead and support team members to create or improve procedures, policies, processes, systems, and technology requirements
• Identify and implement design and process solutions and ensures they are sustained over time
• Hold team accountable to deliver high quality results with passion, energy, and drive to meet business priorities
• Mentor, develop and influence across the business, intentionally building divisional relationships

What You Need

Minimum Qualifications (Required)

• Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 8+ years of work experience
• Ability to communicate complex plans and technical information to team members within and across businesses
• Develop and utilize tools to enhance the company's product/process development or performance
• Requirements management tools, such as JAMA, Integrity, or DOORS.
• Experience managing product defects using tracking tools such as Jira.
• Experience with embedded development using C, C++, Python programming languages.

Preferred Qualifications (Strongly desired):

• Proficient in scripting and analysis using MATLAB.
• Proficient in statistical analysis with Minitab leveraging data analysis to drive decision-making
• Broad base of experience in implementing design methodologies such as DFM, Reliability and Systems Design
• High degree of experience in medical device design (or designing in a highly regulated industry) and ability to utilize Requirements Management Tools and System Modeling Tools
• 3D CAD/CAM software, such as SolidWorks or Creo, etc.
• EDA software, such as Altium.
• Experience with SysML and Model-based Systems Engineering
• Experience with SysML / MBSE software tools

Med Device Compliance (Preferred)

• Divisional expert with extensive experience applying industry standards for device development
• Independent reviewer and advisor for the creation or refinement of engineering documentation, such as the Design History file
• Lead the development of standards and regulations, working closely with functions within and across business

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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